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Biotechnology
The European Commission (EC) has granted marketing authorization for Bimzelx (bimekizumab) for the treatment of adults with active psoriatic arthritis (PsA) and adults with active axial spondyloarthritis (axSpA) including non-radiographic axSpA (nr-axSpA) and ankylosing spondylitis (AS), also known as radiographic axSpA. 7 June 2023
Biotechnology
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) alongside chemotherapy for mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. 6 June 2023
Pharmaceutical
A joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming fall 2023 vaccination campaigns has been issued today by the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA). 6 June 2023
Biotechnology
Belgium’s largest pharma company UCB today revealed that its developmental treatment for adults with hidradenitis suppurativa (HS) has been granted Promising Innovative Medicine (PIM) designation in the UK by the Medicines and Healthcare Products Regulatory Agency (MHRA). 5 June 2023
Biotechnology
The coverage of medicine costs in the USA has come under further question, particularly related to Alzheimer’s disease treatments. 2 June 2023
Biotechnology
As anticipated, Pfizer as secured US Food and Drug Administration approval for its bivalent RSV vaccine, targeting disease caused by RSV in people over the age of 60. 1 June 2023
Biotechnology
Dutch biotech firm Pharming said today that it has entered into a definitive agreement with Swiss pharma giant Novartis to sell its Rare Pediatric Disease Priority Review Voucher (PRV) to Novartis. 1 June 2023
Pharmaceutical
Following a mixed advisory panel vote in late April, the US Food and Drug Administration FDA) said yesterday that it has approved UK pharma major AstraZeneca’s Lynparza (olaparib). 1 June 2023
Pharmaceutical
Shares of US biotech Amylyx Pharmaceuticals fell more than 3% by close of trading Tuesday and a further 2.2% to $23.51 in pre-market activity today, after it said that a European regulatory panel had taken a negative view on its amyotrophic lateral sclerosis (ALS) treatment 31 May 2023
Biosimilars
South Korean drugmaker Samsung Bioepis today announced that the European Commission (EC) has granted marketing authorization for Epysqli, a biosimilar to medicine to AstraZeneca’s Soliris (eculizumab), for the treatment of adult and child patients with paroxysmal nocturnal hemoglobinuria (PNH). 30 May 2023
Pharmaceutical
SKYcovion, the COVID-19 vaccine developed by SK bioscience, an entity of South Korean firm SK Chemicals, has been cleared for marketing by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 30 May 2023
Biotechnology
On the regulatory front, a US Food and Drug Administration (FDA) advisory committee last week came down heavily against approval of Intercept Pharmaceuticals’ obeticholic acid (OCA) as a treatment for pre-clinical cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). Meantime, US biotech Blueprint Medicines announced that the FDA has approved its drug Ayvakit for the all-important indication of indolent systemic mastocytosis. M&A news included gastrointestinal specialist Ironwood Pharmaceuticals agreeing to buy Swiss firm VectivBio, along with its short bowel syndrome drug apraglutide, for $1 billion. Mirati Therapeutics announced that its sitravatinib, in combination with Opdivo, had failed to meet the primary endpoint of a clinical trial in lung cancer, and it would therefore abandon further development. 28 May 2023
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved Inpefa (sotagliflozin), developed by Lexicon Pharmaceuticals. 27 May 2023
Biotechnology
The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended two medicines for approval at its May 2023 meeting. 26 May 2023
Biotechnology
Ultomiris (ravulizumab) has been approved in Japan as the first and only long-acting C5 complement inhibitor for the treatment of adults with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). 26 May 2023
Pharmaceutical
Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. 26 May 2023
Pharmaceutical
The UK’s Medicines and Healthcare products Regulator Agency (MHRA) today announced that new regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the USA. 26 May 2023
Biosimilars
The US Food and Drug Administration (FDA) has approved Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s (NYSE: ABBV) mega-blockbuster drug Humira (adalimumab) biosimilar, the US subsidiary of South Korean biosimilars developer Celltrion Healthcare. 26 May 2023
Biotechnology
Sarepta Therapeutics closed 11% lower following Wednesday’s trading. 25 May 2023
Pharmaceutical
Japanese drugmaker Daiichi Sankyo today announced that Vanflyta (quizartinib) has been approved in Japan for the treatment of acute myeloid leukemia (AML) that is FLT3-ITD mutation positive, with the news surprisingly pushing the firm’s shares down 4.4% to 4,582 yen 25 May 2023
Pharmaceutical
Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024
Biotechnology
US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024
Biotechnology
US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024
Biotechnology
Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024
Pharmaceutical
USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024
Biotechnology
GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024
Biotechnology
French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024
article
The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024
Pharmaceutical
European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024
Pharmaceutical
Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024
Pharmaceutical
Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024
Pharmaceutical
On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024
Pharmaceutical
US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024
Pharmaceutical
Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024
Generics
Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024
Biotechnology
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the medicine sugemalimab (trade name Eqjubi) to treat adult patients with a type of cancer called non-small cell lung cancer (NSCLC ). 31 October 2024
Pharmaceutical
Novartis late yesterday revealed that Scemblix (asciminib) was granted accelerated approval by the US Food and Drug Administration (FDA) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). 30 October 2024
Pharmaceutical
Privately-held US drugmaker Protega Pharmaceuticals says that the US Food and Drug Administration (FDA) has approved Roxybond (oxycodone hydrochloride) immediate-release (IR) CII 10mg tablet for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. 29 October 2024
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